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Assessing Drug-Smoking Interactions Using PBPK Modeling

The prevalence of cigarette smoking remains high globally despite abundant evidence showing that it isn’t good for your health. But, did you know that smoking can affect the metabolism of other drugs and even cause serious drug interactions? In this blog post, I’ll discuss the mechanisms by which smoking can impact pharmacokinetics, how physiologically-based pharmacokinetic … Continued

Leveraging Phoenix for Dissolution Testing to Meet Regulatory Guidelines

During this presentation, Jean-Michel Cardot, professor and head of the Department of Biopharmaceutics and Pharmaceutical Technology at the Auvergne University in France, discussed the tools available to formulation scientists performing dissolution testing and what regulatory guidelines must be considered when performing these tests.

Get Ready for CDISC SEND

In this express webinar led by Chris Lovejoy, learn how NCA data needs to be prepared, transformed, and formatted to be SEND-ready and how Phoenix tools can save time, reduce errors, and increase compliance.

Using Model-based Meta-analysis to Improve Decision-making in Drug Development

Making the right choices in drug development often means the difference between getting a new medication to patients and it ending up in the scrap heap of failed programs. 承認された医薬品および開発中の医薬品の両方に関する公開情報は非常に多く存在します。こうした状況下で、スポンサー企業はどのように臨床試験データに基づいて、開発医薬品の成功への道筋をつける知見を獲得することができるでしょうか?

A Streamlined Approach to Policy 70

David Cornwell, Founder and CEO of PleaseTech and Lora Killian, Synchrogenix Director of Transparency and Disclosure, provided an in-depth review of the full streamlined process created as a result of the partnership between Synchrogenix and PleaseTech.

Leveraging Modeling and Simulation for Neonatal and Infant Drug Development

In this webinar, Certara’s Dr. Alice Ke explained how modeling and simulation aligns with the directionality of regulatory, ethical and testability factors. She focused on the rapid advances in the use of physiologically-based pharmacokinetic modeling (PBPK) to support drug development for neonates and infants.

仮想化と個別化が担う医薬品開発の将来

Today, drug development is carried out in human subjects and animals. However, as computing power and the number of sophisticated technology platforms grow exponentially, and our knowledge of human health and disease increases, the virtualization of clinical research and development will grow steadily.

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